Canada Gazette, Part I, Volume 152, Number 51: Regulations Amending the Pest Control Products Incident Reporting Regulations

December 22, 2018

Statutory authority
Pest Control Products Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Health Canada’s Pest Management Regulatory Agency (PMRA) internal program evaluation and interaction with industry stakeholders have identified areas for improvement in the Pest Control Products Incident Reporting Regulations (IRR).

Complex and ambiguous requirements

The IRR schedule that describes the severity classification for environmental incidents is complex, difficult for registrants to follow, and not of value for identifying the actual implications of incidents. These classifications were based on the criteria established by the United States Environmental Protection Agency (EPA) and the EPA has noted the same issues.

Health Canada scientists validate all incident reports to verify that incidents are assigned the proper degree of severity. It is currently estimated that 5% of reports received are not properly classified.

Furthermore, incidents involving certain animals, such as honeybees or fish, may be classified as either domestic animal incidents or environmental incidents, since some species of animals can be both domesticated and “wild” in the environment. This leads to confusion on the part of regulated parties, and the ambiguity can decrease the ability for Health Canada to identify trends in the data.

Time limits to report incidents are too long in some cases, and too short in others

Currently, all incidents that are classified as having a minor effect on a human, as well as all incidents that are classified as having moderate or minor effects on a domestic animal, and minor effects on the environment, must be accumulated by registrants for a 12-month period and submitted within the prescribed time frames to Health Canada. footnote 1 The 12-month period is not across a calendar year for all registrants and applicants; rather, the period is staggered, based on the name of the registrant or applicant submitting the reports.

This staggered 12-month reporting time limit has also resulted in technical issues, such as slow processing times and forms being rejected due to their size, relating to the use of electronic reporting when submitting a large number of incidents at once.

Furthermore, the EPA requires all incidents classified as having a minor effect on a human or a minor or moderate effect on a domestic animal to be reported on a quarterly basis. This misalignment can lead to inefficiencies for regulated parties training employees to submit incident reports in Canada and the United States (U.S.).

With respect to data analysis, the staggered 12-month reporting time limit has resulted in difficulty in consistently identifying trends in pest control products that have multiple registrants, thus making it difficult to monitor compliance, analyze data and plan outreach activities. The 12-month reporting period is also too long when trying to compare with EPA incident data, because the same data is reported to the EPA every 3 months (quarterly) instead of every 12 months. The staggered 12-month reporting time limit makes it challenging to accurately report data in the Incident Reporting Program’s annual reports, which reflect information received in a calendar year.

Currently, incidents of packaging failure are required to be reported on a monthly basis. Packaging failure incident reports received by the PMRA to date have not indicated that the level of risk identified in these reports warrant the short reporting time limit of one month. Registrants and applicants have, as a result, requested that the time limit for these incidents be changed to quarterly, rather than monthly.

Food residue incident reports do not serve their intended purpose of improving health and environmental protection

Currently, incidents must be reported where the effect is a pesticide residue in food, detected in an amount that would result in the food being prohibited for sale under the Food and Drugs Act. In the five incidents reported to date since the inception of the Pesticide Incident Reporting Program in 2007, no information has been received in the incidents that would require a risk of excessive residues in food for sale in Canada to be addressed. Therefore, this requirement has not met its intended purpose as laid out in the Regulations.

Reporting requirements when registrations are transferred or cancelled are not comprehensive

If a registrant ceases for any reason to be the registrant of a particular pest control product or transfers the registration to another registrant, then, within 15 days of them ceasing to be a registrant, the current IRR requires them to submit any outstanding annually accumulated incident reports, as well as annual summaries. This limitation to only receiving annually accumulated incident reports, rather than any incident reports (such as reports required to be provided within a shorter time period), may impede Health Canada’s ability to receive crucial incident reports that identify more severe incidents. For example, certain incidents that involve the death of an animal in the environment are classified as “moderate” under the current system, and the incidents could potentially go unreported on transfer.

Trigger for providing an annual summary

A registrant must file an annual summary with respect to an active ingredient if it has been implicated in at least 10 incident reports in the same year. Annual summaries that pertain to multiple incident categories (e.g. human, domestic animal, or the environment) are not useful for identifying trends. A trend is specific to the category of incident. For example, the risk of an animal in the wild eating rodenticides is very different from the risk of a human developing a skin rash, which is different from the risk of grass wilting where a rodenticide has been placed. The content of an annual summary is far more challenging to prepare if regulated parties must perform a critical analysis of why incidents occurred in domestic animals, humans, and the environment, when each of these incidents occurred only a limited number of times.

Inconsistency of terms used between the Pest Control Products Incident Reporting Regulations and the Pest Control Products Act

The IRR currently uses “file,” “filing,” and its related verb forms when describing the submission of an incident report. This is inconsistent with the Pest Control Products Act, which states “a registrant shall report any prescribed information.”

Background

The Minister of Health’s primary mandate under the Pest Control Products Act (PCPA) is to prevent unacceptable risks to human health and the environment from the use of pest control products (pesticides). Under the PCPA, pesticides must be registered or otherwise authorized by the Minister of Health before they can be used in Canada. While pesticides are tested and evaluated for safety before they are registered, some adverse effects may not become evident until the product is used under “real-life” circumstances.

The PCPA requires registrants, and applicants for the registration of a pesticide, to report incidents involving their pesticide. The reporting process is set out in the IRR. Registrants and applicants are required by the IRR to submit reports on incidents

Incidents include those that occur in either Canada or the U.S. The reporting of incidents that occur in the U.S. is only mandatory if the incident falls within any of the following categories described in section 2 of the current IRR:

If 10 or more incidents involving a given active ingredient occur in a single year, registrants and applicants must submit an annual summary that describes the incidents that occurred and analyzes the changes in the risk profile of the active ingredient from year to year.

Health Canada evaluates all reported incidents to identify unacceptable risks to health or the environment, and incorporates the findings into its pesticide regulatory decisions. Since the Pesticide Incident Reporting Program’s establishment, Health Canada has investigated a number of reported pest control product incidents. Some investigations have resulted in regulatory actions, such as amending the use instructions or changing the packaging.

Health Canada maintains information on the canada.ca website regarding the Pesticide Incident Reporting Program.

Objectives

Without affecting the long-term outcome of improving health and environmental protection, the proposed amendments would

Description

In order to meet the objectives of this proposal, the amendments would do the following.

Clarify the definition of “incident”

The proposed amendments would exclude effects from being considered an incident if they are observed on the intended target of the pest control product.

Remove ambiguity in animal and environmental reporting

The proposed amendments would change the classification of incidents from those affecting “domestic animals” and those affecting “the environment” to those affecting “animals” and those affecting “terrestrial or aquatic plants.” This would remove the ambiguity previously identified, without affecting the total number of incident reports that would be submitted.

The term “domestic animal” would be maintained, but only so that incidents involving domestic animal death occurring in the U.S. would continue to be reported.

Remove requirements to classify incidents by their degree of severity, except for the most serious cases

The proposed amendments would require a degree of severity to be classified only when the effects are severe, meaning a human incident that results in death, or that is classifiable as “major” (i.e. is life-threatening, results in adverse reproductive or developmental effects, or results in chronic disability), or an animal incident that results in death. Every other incident would no longer require a degree of severity to be assigned by the registrant or applicant, resulting in reduced administrative burden on regulated parties. Since Health Canada scientists validate the degree of severity for all incident reports, the proposed amendments would not affect the level of scientific rigour applied to the analysis, thus continuing to meet Health Canada’s long-term outcomes.

Harmonize reporting timelines for all incidents except for the most serious cases

The proposed amendments would eliminate the 12-month and one-month time limits for most reports, and instead require that incidents be accumulated over a 3-month period (i.e. quarterly), and then reported within 2 months from the end of that quarter. This change would more closely align the reporting process for registrants who are required to report incidents in both Canada and the United States. It also addresses the technical and analytical issues that arise from the staggered 12-month reporting period.

Certain types of incidents are sufficiently serious that incident reports should be submitted faster than the possible maximum of five months:

Remove the requirement to report incidents involving excessive residues in food

The proposed amendments would remove reporting requirements for residues in food, reducing burden on regulated parties without compromising Health Canada’s long-term outcomes.

Expand reporting requirements when registrations are transferred or cancelled

The proposed amendments would require registrants to provide all incident reports, not just those for minor incidents, which a registrant receives if they cease to be a registrant for any reason, including the transfer or cancellation of a product’s registration. It is necessary for Health Canada to receive all relevant incident reports, not just reports for minor incidents, when a registrant ceases to be a registrant. This would improve Health Canada’s ability to monitor and respond to potential issues and ensure that incidents continue to be reported for the period during which a registrant was responsible for their product.

Revise the trigger for providing an annual summary

The proposed amendments would require regulated parties to provide an annual summary when the active ingredient is implicated in at least 10 incidents involving the same subject, such as 10 incidents involving animals or 10 incidents involving humans, rather than in at least 10 incidents across all subjects. This would reduce the number of summaries reported, reducing administrative burden on registrants, while still allowing the capture of the most pertinent annual summaries. Streamlining the focus of the annual summary will also improve the ability to identify trends, since more information relating to similar incidents would be available to analyze.

Align the wording of the Pest Control Products Incident Reporting Regulations with the Pest Control Products Act and make other miscellaneous changes

The proposed amendments would align the words used in the IRR more consistently with what is in the PCPA. For example, using “provide” (“fournir” in French) instead of “file” (“déclarer” in French); and “rapport” (instead of “déclaration”) in French. Similarly, the use of the phrase “complete and exact,” in the context of incident reports that regulated parties must provide, is unnecessary, since it is assumed that any information provided in an incident report must be done completely and accurately. As a result, the phrase “complete and exact” would be removed.

“One-for-One” Rule

The proposed regulatory amendments are expected to decrease administrative costs for registrants. Therefore, the “One-for-One” Rule applies and the proposal is considered an “OUT” under the Rule. The total annualized administrative cost savings for all regulated parties would be approximately $28,752, or $41 per regulated party.

This reduction would be largely due to

These results are based on the following assumptions:

Health Canada obtained information regarding the number, type, and submission frequency of incident reports from its internal databases.

Health Canada estimated the amount of time to complete an incident report, the amount of time to calculate the degree of severity, and the amount of time to complete an annual summary report, based on consultation with industry stakeholders from CropLife Canada and the Canadian Consumer Specialty Products Association (CCSPA). Wage rates were based on data in the Statistics Canada 2010–2011 Labour Force Survey.

Small business lens

The small business lens does not apply to this proposal, as there are insignificant changes to costs for small business.

Consultation

The need to amend the IRR has been discussed with industry stakeholders over several years.

The initial proposal was discussed with industry stakeholders, including CropLife Canada and the CCSPA, starting in 2014. On May 22, 2015, a pre-consultation document that outlined the proposed amendments was published online for a 30-day public comment period.

Industry associations were generally supportive of the proposed amendments, as they would simplify the reporting process and decrease regulatory and administrative burden. Some concerns had been raised by individual industry members that the reduction in time limits for some incidents from annual to quarterly reporting is not preferred.

While many suggestions were taken into consideration during the development of the proposed amendments, Health Canada notes that the shift to quarterly reporting is generally aligned with the requirements for reporting incidents in the United States, and that, while this may require some incident reports to be submitted sooner than before, the number of incident reports that would be submitted would not increase, and other types of reports would be submitted later than before. Moreover, requiring that certain reports be provided quarterly assists Health Canada in identifying risks that need to be managed and meeting its health and environmental objectives under the PCPA.

Regulatory cooperation

Health Canada has engaged with its regulatory counterparts in the EPA since before the inception of the program in 2007. In fact, the EPA’s incident reporting program was used as the model for the Canadian program, and the IRR were drafted with the U.S. program in mind. Since 2007, Health Canada and the EPA have met annually and discussed their respective programs, as well as anticipated regulatory changes.

In spring 2018, Health Canada consulted with its regulatory counterparts at the EPA regarding the proposed amendments to incident reporting. EPA officials were overall supportive of the proposed amendments, and did not indicate that the areas of misalignment between Canadian and U.S. requirements posed a risk to trade.

For the majority of incidents, the timelines for a regulated party to submit an incident report will be identical, resulting in alignment between the two jurisdictions.

Certain areas of this regulatory proposal remain out of alignment with the U.S. regulations. However, for these few unaligned areas, Health Canada has determined that the proposed time limits for submitting incident reports, and the detail required to be provided in the reports, is sufficient to effectively monitor and assess pesticide-related incidents. In some cases, such as the elimination of degrees of severity for environmental incidents, the U.S. has indicated that they would like to align their regulations with the Canadian proposal.

Moreover, the Pesticide Incident Reporting Program pertains only to data points that inform decision making, and not to the direct trade of goods. As a result, there are no direct implications to Canada–U.S. trade as a result of differences in incident reporting, and it is not anticipated that there will be any impacts on Canada–U.S. trade as a result of the few remaining differences between Canadian and U.S. incident reporting requirements.

Rationale

Benefits

The proposed amendments would provide the potential for health and safety benefits, as well as environmental benefits, by improving the ability for Health Canada to analyze trends in incident reports that are provided. By improving the ability to analyze trends, Health Canada would be better able to identify unacceptable risks to health or the environment more quickly, and incorporate those findings into pesticide regulatory decisions in a more responsive manner.

The proposed amendments would also simplify the process for regulated parties to prepare and submit incident reports, resulting from the removal of the degree of severity classification requirements, the removal of the requirement to submit incidents pertaining to excessive food residues, and changes to reporting requirements to align more closely with those of the United States. This, in turn, would reduce the amount of time that it takes to fulfill regulatory requirements and therefore reduce administrative burden.

Finally, the proposed amendments would halve the number of annual summaries that would need to be submitted by regulated parties per year without compromising health and safety, or the environment, which in turn would decrease the burden on regulated parties associated with preparing and submitting the summaries. As a result of the reduced number of summaries to be processed, the Government of Canada would also realize efficiencies.

The proposed amendments, through the syntax and grammar changes, would improve consistency and readability between the IRR and the PCPA, which in turn would remove ambiguity and therefore improve the quality of reports submitted.

Costs

The proposed amendments would impose a small, one-time upfront compliance cost on regulated parties of $35,210 for all registrants, or approximately $50 per registrant, to familiarize themselves with the new obligations.

The proposed amendments would also impose a small, one-time upfront cost on the Government of Canada, to modify the electronic forms that are used to report incidents.

Taken on the whole, the potential benefits that would be realized by the amendments far outweigh the one-time costs that would be borne by regulated parties and the Government of Canada.

Implementation, enforcement and service standards

To provide registrants and applicants with time to adjust to the amended Regulations, Health Canada is proposing a delayed coming into force as part of the implementation. The Regulations would come into force on the first of January that falls at least six months after the day on which they are published in the Canada Gazette, Part II, to ensure that there is consistent reporting by regulated parties during the year the new requirements would come into effect. All incidents about which regulated parties received information before the amended Regulations come into force would continue to be subject to the categorization and reporting timelines in the current Regulations. Any regulated party in the middle of their annual reporting cycle when the amended Regulations come into force would be required to submit any incident reports that have not yet been submitted by a prescribed date.

Health Canada promotes, maintains and enforces compliance with the PCPA through active prevention; inspections, including surveillance; and enforcement response actions. Active prevention aims to educate, facilitate and promote compliance as well as to communicate regulatory information. Inspections are designed to determine the level of compliance of users, distributors and registrants of pesticides with the general provisions of the PCPA and its regulations, as well as specific terms and conditions of registration.

Enforcement response may include

Compliance with the PCPA and its regulations is achieved through a network of officers and inspectors across Canada. Health Canada regional offices also have formal agreements with provincial pesticide regulatory departments, providing a basis to collaborate with them in inspections and in the development and delivery of compliance activities.

Non-compliance with most provisions of the amended IRR would continue to be subject to the administrative monetary penalties regime, namely Part 4 of Schedule 1 to the Agriculture and Agri-Food Administrative Monetary Penalties Regulations Respecting the Pest Control Products Act and Regulations. As a result, should administrative monetary penalties be used as a component of the enforcement response, violations of these IRR provisions may result in a warning or a penalty. The maximum penalty for a violation is set out in the Agriculture and Agri-Food Administrative Monetary Penalties Act. Should the proposed amendments to the IRR be made, amendments to Part 4 of Schedule 1 would be required to align the violations with the amended IRR. These amendments would be published, and come into force, at the same time as the amendments to the IRR come into force (meaning the first of January that falls at least six months after the amendments are published in the Canada Gazette, Part II).

Health Canada follows an established compliance policy to promote and enhance fair treatment of the regulated community. This policy is available on the canada.ca website.

Contact

Please direct all questions and inquiries to

Jordan Hancey
Health Canada
Pest Management Regulatory Agency
Policy, Communications and Regulatory Affairs Directorate
2720 Riverside Drive
Ottawa, Ontario
K1A 0K9
Email: hc.pmra.regulatory.affairs-affaires.reglementaires.arla.sc@canada.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 67(1) footnote a of the Pest Control Products Act footnote b, proposes to make the annexed Regulations Amending the Pest Control Products Incident Reporting Regulations.

Interested persons may make representations concerning the proposed Regulations within 45 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Jordan Hancey, Director, Policy and Regulatory Affairs Division, Policy, Communications and Regulatory Affairs Directorate, Pest Management Regulatory Agency, Department of Health, Postal Locator 6607, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (fax: 613-736-3659; email: HC.pmra.regulatory.affairs-affaires.reglementaires.arla.SC@canada.ca).

Ottawa, December 13, 2018

Jurica Čapkun
Assistant Clerk of the Privy Council

Regulations Amending the Pest Control Products Incident Reporting Regulations

Amendments

1 The title of the French version of the Pest Control Products Incident Reporting Regulations footnote 2 is replaced by the following:

Règlement sur les rapports d’incident relatif aux produits antiparasitaires

2 (1) Subsection 1(1) of the Regulations is replaced by the following:

Definitions

(1) The following definitions apply in these Regulations.

Act means the Pest Control Products Act. (Loi)

animal means invertebrates and vertebrates, excluding humans. (animal)

domestic animal means an animal that is under the control of humans and dependent on them for its survival. (animal domestique)

incident means an incident whose effects relate to the health or environmental risks or the value of a pest control product. It does not include an incident that results from

incident report means a report that contains the information described in section 3 and that is received by the Minister from a registrant or an applicant. (rapport d’incident)

(2) Subsection 1(2) of the French version of the Regulations is replaced by the following:

Définition de rapport d’incident

(2) Pour l’application de la définition de rapport d’incident au paragraphe (1), il n’est pas nécessaire que les renseignements soient justifiés ou corroborés par le titulaire ou le demandeur d’homologation pour faire l’objet d’un rapport.

3 Section 2 of the Regulations is replaced by the following:

Incident categories

2 Incidents are classified according to the subject and effects of the exposure to the pest control product into the following categories:

4 Sections 6 to 12 of the Regulations are replaced by the following:

Language of reports

6 (1) Incident reports must be provided in English or French.

Translation delays

(2) In the case of a scientific study published in a language other than English or French, if the translation of the study cannot be completed within the prescribed time for providing the incident report, the registrant or applicant must provide the Minister with a summary of the study, in English or French, when the incident report is provided.

Translated study

(3) In a case described in subsection (2), the registrant or applicant must send the completed translated study as soon as possible after the incident report is provided.

Incident Reports

Incidents in Canada

7 Every registrant and applicant must provide to the Minister, in accordance with the time limits specified in sections 10, 11.1 and 12, any information set out in subsection 3(1) that they receive about any incident that occurs in Canada that corresponds to any of the categories described in paragraphs 2(a) to (g).

Incidents in the United States

8 Every registrant and applicant must provide to the Minister, in accordance with the time limits specified in sections 10 and 12, any information set out in subsection 3(1) that they receive about any incident that occurs in the United States that corresponds to any of the following categories:

Scientific studies

9 Every registrant and applicant must provide to the Minister, in accordance with the time limit specified in section 11, any information set out in subsection 3(2) about an incident whose effects are identified in a scientific study.

Time Limits

Time limit — 15 days

10 Every registrant and applicant must provide an incident report within 15 days after the day on which they receive information about any incident that corresponds to any of the following categories set out in section 2:

Time limit — 30 days

11 Every registrant and applicant must provide an incident report within 30 days after the day on which they receive information about any incident whose effects are identified in a scientific study.

Time limit — 90 days

11.1 Every registrant and applicant must provide an incident report within 90 days after the day on which they receive information about any incident that occurs in Canada and whose effect is an animal death.

Time limit — table

12 Every registrant and applicant must accumulate the information that they receive in a reporting period set out in column 1 of the table to this section about incidents in the following categories and provide the required incident reports by the date set out in column 2:

TABLE

 

Item

Column 1

Reporting period

Column 2

Deadline to provide report

1

January 1 to March 31

May 31

2

April 1 to June 30

August 31

3

July 1 to September 30

November 30

4

October 1 to December 31

February 28 or, in the case of a leap year, February 29

5 Section 13 of the Regulations is repealed.

6 Sections 14 to 17 of the Regulations are replaced by the following:

No longer a registrant

14 (1) If a registrant ceases for any reason to be the registrant of a particular pest control product, they must provide the incident reports described in sections 10 to 12 and the annual summary described in section 15, with respect to all information that they receive about that product before the day on which they cease to be a registrant, within one of the following time limits:

Shorter reporting period

(2) Accumulated incident reports described in section 12 and annual summaries described in section 15 that are provided in accordance with subsection (1) may pertain to a reporting period shorter than the prescribed period.

Annual Summary

When annual summary required

15 (1) A registrant must provide the Minister with an annual summary with respect to an active ingredient if

(1.1) For the purposes of this section, the term year means a calendar year.

Content

(2) The annual summary must contain the following information:

Timing

(3) The annual summary must be provided by March 31 of the year that follows the year during which the registrant received information about the incidents described in subsection (1).

Dangerous Situation

At Minister’s request

16 Every registrant must provide the Minister, within 24 hours, with the information set out in subsection 3(1) that they receive and that has not already been reported if the Minister requests it for the purpose of responding to a situation that endangers human health, animal health or terrestrial or aquatic plants.

Records

Keep and submit at Minister’s request

17 Every registrant and applicant must keep a record of every completed incident report and any information they have that relates to or is in connection with that report for six years after the day on which the report is provided to the Minister. The record must be provided to the Minister, on request, for the purpose of making comparisons or a historical analysis of the incidents or to permit the Minister to exercise powers under the Act.

7 Section 18 of the French version of the Regulations is replaced by the following:

Rapports d’incident et renseignements additionnels

18 (1) Sous réserve du paragraphe (2), le ministre verse au Registre les rapports d’incident portant sur tout incident dont l’effet est associé à un produit antiparasitaire homologué ainsi que tout renseignement additionnel — notamment des avis ou des observations utiles — fourni volontairement par le titulaire ou le demandeur d’homologation à l’appui des rapports.

Exclusion

(2) Le ministre retire des rapports d’incident et des renseignements additionnels tout renseignement personnel au sens de l’article 3 de la Loi sur la protection des renseignements personnels.

8 The schedule to the Regulations is repealed.

Transitional Provisions

Definition of Former Regulations

9 For the purposes of sections 10 to 13, Former Regulations means the Pest Control Products Incident Reporting Regulations as they read immediately before these Regulations come into force. (règlement antérieur)

Sections 10 to 12

10 Sections 10 to 12 of the Former Regulations continue to apply with respect to any information a registrant or applicant receives prior to the date of the coming into force of these Regulations about any incident corresponding to the categories set out in those sections.

Section 13

11 A registrant or applicant who, in the year preceding the date of the coming into force of these Regulations, accumulates information in accordance with section 13 of the Former Regulations must file the incident reports referred to in that section for the portion of the reporting period immediately preceding the date of the coming into force of these Regulations within two months of that date.

Subsection 14(3.1)

12 Subsection 14(3.1) of the Former Regulations continues to apply with respect to a registrant that ceases for any reason to be the registrant of a particular pest control product prior to the date of the coming into force of these Regulations.

Section 15

13 A registrant or applicant who, in the year preceding the date of the coming into force of these Regulations, receives information in accordance with the Former Regulations about any incident that is associated with one of its pest control products must, by March 31 of the year these Regulations come into force, file an annual summary with respect to any active ingredient that is a component of one of its pest control products and that is implicated in at least 10 incidents about which it has received information in that calendar year.

Coming into Force

14 These Regulations come into force on the January 1 that follows the sixth month period after the date they are published in the Canada Gazette, Part II.